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Truqap (capivasertib)
Australian Prescription Medicine Decision Summary
Published
Product name
Truqap
Active ingredient
Capivasertib
Submission type
Category A (New Chemical Entity)
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Truqap, in combination with fulvestrant, was approved for the for the treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer following recurrence or progression on or after an endocrine-based regimen.
How this medicine works
Truqap (capivasertib) is an anti-cancer drug that blocks the activity of a protein called AKT, which is important for cell growth and survival. AKT is often overactive in cancer cells, helping them to grow and survive. Capivasertib can stop the growth of cancer cells by blocking AKT. It has been shown to be effective in reducing the growth of cancer cells in the laboratory and in animal models. In this submission, capivasertib was approved for use in combination with another anti-cancer drug, fulvestrant. Combined treatment with capivasertib and fulvestrant demonstrated a greater anti-tumour response than with fulvestrant alone.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy studies conducted in humans) and risk management plan information submitted by the sponsor.
Consumer Medicine Information (CMI)
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMIs can be accessed through the ARTG details hyperlink below.
Product Information (PI)
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PIs can be accessed through the ARTG details hyperlink below.
Sponsor
Other resources
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
For advice on prescription medicines, over the counter medicines and other medicines (including complementary medicines) call Medicines Line.
For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.